Exelon Patch (rivastigmine transdermal system) is a reversible cholinesterase inhibitor and is known chemically as (S)- 3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in Poxet water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate.
The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27.
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Exelon Patch (rivastigmine transdermal system) is for transdermal administration. The patch comprises a four-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration.
Figure 1: Cross Section of the Patch
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| Layer 1 | Backing Film |
| Layer 2 | Drug Product (Acrylic) Matrix |
| Layer 3 | Adhesive (Silicone) Matrix |
| Layer 4 | Release Liner (removed at time of use) |
Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E.
SIDE EFFECTS:Nausea, vomiting, loss of appetite/weight loss, diarrhea, weakness, dizziness, drowsiness, shakiness (tremors), and skin irritation at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these serious side effects occur: slow/irregular heartbeat, fainting, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, seizures, trouble urinating.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS:Before using rivastigmine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing/lung problems (such as asthma, COPD-chronic obstructive pulmonary disease), stomach/intestinal problems (such as ulcers, bleeding), heart problems (such as sick sinus syndrome, other conduction disorders), fainting, seizures, problems urinating (such as due to enlarged prostate).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
While wearing your patch, avoid exposing it to direct heat (such as prolonged direct sunlight, heating pads, electric blankets, heat lamps, saunas, hot tubs). Heat may cause more drug to be released into your body, increasing the chance of side effects.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
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